Hutchmed Advances ORPATHYS-TAGRISSO Lung Cancer Treatment Filings in Europe, Japan

04:20 AM EST, 11/02/2026 (MT Newswires) -- Hutchmed (HCM) said Monday that European and Japanese regulators have accepted filings for its Orpathys combination with AstraZeneca's (AZN) Tagrisso to treat certain patients with MET-driven, EGFR-mutated non-small cell lung cancer. The company said the European Medicines Agency validated and accepted AstraZeneca's marketing authorization application. In Japan, the Ministry of Health, Labour and Welfare also accepted AstraZeneca's new drug application for review. The company said the filings are supported by results from the phase III Saffron trial, which showed the combination reduced the risk of disease progression or death by 45% and the risk of death by 32% versus chemotherapy. The combination extended median progression-free survival to 7.6 months from 5.4 months and median overall survival to 17.8 months from 12.9 months. According to Hutchmed, the treatment's safety profile was consistent with the known profiles of both medicines, with no new safety concerns.